Bander Ureteral Diversion Stent Set: Used for intraoperative placement to stent the ureter and provide drainage of urine from the kidney to the external stoma during ureteroileal conduit construction and continent urinary diversions.
Dretler Ureteroscopy Stent Set: This device is intended for post-ureteroscopy stenting of the ureter.

Device Description

The Bander Ureteral Diversion Stent Set features a pigtail ureteral stent constructed of either silicone or polyurethane. The stent ranges from 4.7 to 8.4 French and the overall lengths range from 70 to 90 centimeters. The pigtail retention coil can be open or closed, tapered or nontapered, but all configurations contain 6 evenly space sideports continue for the first 10 centimeters of the stent body from the pigtail. In addition to the 90° rotated sideports, some of the stents feature ink markings to aid in placement. The Bander Ureteral Diversion Stents Sets are supplied with either one or two stents. When two stents are included, a right and left are color-coded red and blue, respectively. The Bander Ureteral Diversion Stent Sets are also supplied with a straight wire guide. The accessories supplied with the Bander Ureteral Diversion Stent Sets include an adapter with an O-ring and a catheter retainer.

The Dretler Ureteroscopy Stent Set includes a 4.7, 6.0, or 8.4 French stent is manufactured using a polyurethane material and has a single pigtail at the distal end with 3 evenly spaced sideports. The stent comes with incremental ink markings and is 125 centimeters in length. The Dretler Ureteroscopy Stent Sets are supplied with an accessory connector with an O-ring and a wire guide.

AI/ML Overview

The provided document is a 510(k) summary for the Bander Ureteral Diversion Stent Set and Dretler Ureteroscopy Stent Set. It describes the devices, their intended use, and compares them to a predicate device to demonstrate substantial equivalence.

Based on the document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in numerical form. Instead, the document indicates that various tests were performed to ensure "reliable design and performance under the specified testing parameters" and to meet "design input requirements based on the intended use." The reported device performance is that the devices "met the design input requirements."

Acceptance Criteria (Implied)	Reported Device Performance
Reliable Design	Subject devices met design input requirements.
Reliable Performance under specified testing parameters	Subject devices met design input requirements.
MRI Safety	Testing conducted, results suggest acceptable performance.
Dimensional Accuracy	Testing conducted, results suggest acceptable performance.
Tensile Strength	Testing conducted, results suggest acceptable performance.
Shaft and Curl Elongation	Testing conducted, results suggest acceptable performance.
Retention Strength	Testing conducted, results suggest acceptable performance.
Flow Rate	Testing conducted, results suggest acceptable performance.
Radiopacity	Testing conducted, results suggest acceptable performance.
Kink Resistance	Testing conducted, results suggest acceptable performance.
Compatibility with components	Testing conducted, results suggest acceptable performance.
Artificial Urine Soak (Biocompatibility/Material Integrity)	Testing conducted, results suggest acceptable performance.
Accelerated Aging (Shelf-life)	Testing conducted, results suggest acceptable performance.
Packaging integrity (for Tyvek polyethylene peel-open pouch)	Testing conducted, results suggest acceptable performance.
Sterilization effectiveness (EtO)	Testing conducted, results suggest acceptable performance.

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for the conducted tests. It only lists the types of tests performed (e.g., MRI Safety Testing, Dimensional, Tensile Strength, etc.).

No information is provided regarding the provenance (country of origin, retrospective or prospective) of any data beyond the tests being conducted internally by Cook Incorporated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not available in the provided document. The document describes engineering and material performance tests, not studies requiring expert clinical interpretation or ground truth establishment in a medical context.

4. Adjudication method for the test set

This information is not available in the provided document. As mentioned above, the tests are primarily engineering performance tests, not clinical studies requiring adjudication of outcomes or interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no indication of an MRMC comparative effectiveness study, an AI component, or human reader improvement in this document. This document is for a ureteral stent, a physical medical device, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

There is no indication of any algorithm-only or AI performance testing. This document is for a physical medical device.

7. The type of ground truth used

For the engineering and material tests listed, the "ground truth" would be established by physical measurements, standardized testing procedures, and material specifications. For example, for "Dimensional" testing, the ground truth would be the expected dimensions based on design specifications. For "Tensile Strength," the ground truth would be the strength requirements described in internal design documents or relevant material standards.

8. The sample size for the training set

This information is not applicable as the document describes a physical medical device, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable as the document pertains to a physical medical device and does not involve machine learning or training sets.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the Cook Medical logo, which is a white "COOK" on a red background, with the word "MEDICAL" underneath. Below the logo, the text "510(k) Summary" is displayed in a larger, bold font. The logo and text are centered.

COOK INCORPORA 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM

K181971 Bander Ureteral Diversion Stent Set Dretler Ureteroscopy Stent Set 21 CFR $807.92 Date Prepared: April 4, 2019

Submitted By:

Applicant: Primary Contact: Secondary Contact: Applicant Address:

Primary Contact Number: Secondary Contact Number: (812) 335-3575 x105147 Contact Fax Number:

Cook Incorporated Paul Meyer Andrew Breidenbach Cook Incorporated 750 Daniels Way Bloomington, IN 47404 (812) 335-3575 x105299 (812) 332-0281

Device Information:

Trade Name:	Bander Ureteral Diversion Stent SetDretler Ureteroscopy Stent Set
Common Name:	Ureteral stent
Classification Name:	Ureteral stent,
Regulation:	21 CFR §876.4620
Product Code:	FAD, Class II

Predicate Device:

The Percuflex™ Urinary Diversion Stent Set (K830803, Boston Scientific) is designed to be used following percutaneous, endoscopic, or operative procedures. The design features a pigtail curl on the distal end to prevent migration and a luer-lock connection on the proximal end. The stent has graduation markings to aid in placement. The set includes two stents (color-coded left and right sides), a guidewire, catheter adapters, and a drainage bag connector.

De vice Description:

The Bander Ureteral Diversion Stent

{1}------------------------------------------------

K181971 Page 2 of 6

10 centimeters of the stent body from the pigtail. In addition to the 90° rotated sideports, some of the stents feature ink markings to aid in placement.

The Bander Ureteral Diversion Stents Sets are supplied with either one or two stents. When two stents are included, a right and left are color-coded red and blue, respectively.

The Bander Ureteral Diversion Stent Sets are also supplied with a straight wire guide.

The accessories supplied with the Bander Ureteral Diversion Stent Sets include an adapter with an O-ring and a catheter retainer.

The Dretler Ureteroscopy Stent

The Dretler Ureteroscopy Stent Sets are supplied with an accessory connector with an O-ring and a wire guide.

Intended Use :

The Bander Ureteral Diversion Stent

The Bander Ureteral Diversion Stent Sets are used for intraoperative placement to stent the ureter and provide drainage of urine from the kidney to the external stoma during ureteroileal conduit construction and continent urinary diversions.

The Dretler Ureteroscopy Stent

The Dretler Ureteroscopy Stent Set is intended to be used for post-ureteroscopy stenting of the ureter.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in white, large, sans-serif font, and the word "MEDICAL" is in white, smaller, sans-serif font.

Comparison to Predicates:

The Bander Ureteral Diversion Stent Set

		PREDICATE DEVICE	SUBJECT DEVICE
		Percuflex™ Urinary DiversionStent Set (K830803)	Bander Ureteral Diversion Stent Set(Subject of this Submission)
	Manufacturer	Boston Scientific	Cook
	Regulation Number	Unclassified	21 CFR §876.4620
	Product Code	LJE	FAD
	Classification Name	Catheter, Nephrostomy	Stent, Ureteral
	Device Class	II	Identical
Indications for Use		The Percuflex™ Urinary DiversionStent Set is used for drainagefollowing percutaneous, endoscopic,or operative procedures.*	Used for intraoperative placement tostent the ureter and provide drainageof urine from the kidney to theexternal stoma during ureteroilealconduit construction and continenturinary diversions.
Model Number		M0061602XX	025XXX[-XX]
Kit Components		Stent Wire guide Catheter Connectors* Tube Connectors*	Stent Wire guide Drainage tube adapter Stent retainer
Stent	Outer Diameter (Fr)	Pediatric: 4.0, 5.0, 6.0Adult: 6, 7, and 8	Adult: 4.7, 6.0, 7.2, and 8.4
	Length (cm)	Pediatric: 30Adult: 70	Adult: 70, 75, and 90
	Material	C-Flex Thermoplastic Elastomer	silicone or polyurethane
	Tip Configuration	Closed and Open Tip	Identical
	Sideport Size (gage)	Unknown	Curl: 18, 19, or 21Shaft: 17, 18, or 21
	Ink	Unknown	Black Ink
Indwelling Time		≤ 90 days*	≤ 90 days
Packaging		Unknown	Tyvek polyethylene peel-open pouch
Sterilization		Unknown	EtO
Shelf Life		Unknown	3 years

If information was not specified within the predicate 510(k), then information was obtained from currently available marketing information and is discussed further in the Substantial Equivalence discussion as appropriate. See AppendixF for predicate marketing data.

The subject device, the Bander Ureteral Diversion Stent Set is similar to the Percuflex™ Urinary Diversion Stent Set (K830803, Boston Scientific) in terms of intended use and technological characteristics. The minor differences from the predicate devices include:

Similar but not identical indications for use
Product Code ●
Additional stent dimensions ●
Different stent materials
Indwell time ●
Packaging ●

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the Cook Medical logo. The logo is set against a red background. The word "COOK" is written in white, and the word "MEDICAL" is written in white below the word "COOK".

K181971 Page 4 of 6 NWW.COOKMEDIC.

Sterilization ●
Shelf-life ●

Reference devices used to help support a substantial equivalence determination for the Bander Ureteral Diversion Stent include:

Cook Black Silicone Filiform Double Pigtail Stent Set (K172017) ●
Surgitek Urinary Diversion Stent (K800109) ●
Bard Ureteral Stent (K823487) ●

The Dretler Ureteroscopy Stent Set

	PREDICATE DEVICE	SUBJECT DEVICE
	Percuflex™ Urinary DiversionStent Set (K830803)	Dretler Ureteroscopy Stent Set(Subject of this Submission)
Manufacturer	Boston Scientific	Cook
Regulation Number	Unclassified	21 CFR §876.4620
Product Code	LJE	FAD
Classification Name	Catheter, Nephrostomy	Stent, Ureteral
Device Class	II	Identical
Indications for Use	The Percuflex™ Urinary DiversionStent Set is used for drainagefollowing percutaneous,endoscopic, or operativeprocedures.*	Used for post-ureteroscopy stenting ofthe ureter.
Model Number	M0061602XX	0255XX[-XX]
Kit Components	• Stent• Wire guide• Catheter Connectors• Tube Connectors	• Stent• Wire guide• Catheter adapter
Stent Outer Diameter(Fr)	Pediatric: 4.0, 5.0, 6.0Adult: 6, 7, and 8	4.7, 6, and 8.4
Stent Length (cm)	Pediatric: 30Adult: 70	125
Stent Material	C-Flex Thermoplastic Elastomer	Polyurethane
Stent Tip Configuration	Closed and Open Tip	Open Tip
Sideport Size (gage)	Unknown	18, 19, or 21
Stent Marker BandMaterial	Unknown	Black Ink
Indwelling Time	≤ 90 days*	≤ 90 days
Packaging	Unknown	Tyvek polyethylene peel-open pouch
Sterilization	Unknown	EtO
Shelf Life	Unknown	3 years

*If information was not specified within the predicate 510(k), then information was obtained from currently available marketing information and is discussed further in the Substantial Equivalence discussion as appropriate. See AppendixF for predicate marketing data.

{4}------------------------------------------------

750 DANIELS WAY, P.O. B BLOOMINGTON IN 47402-0489 II 9 312 339 2235 TOULEREE: 800 457 WWW.COOKMEDICAL

The subject device, the Dretler Ureteral Diversion Stent Set is similar to the Percuflex™ Urinary Diversion Stent Set (K830803. Boston Scientific). The Dretler Ureteral Diversion Stent Set and the predicate are similar in that these devices have similar designs, intended use, and technological characteristics. The modifications from the predicate devices include:

. A more specific indications for use
Product Code ●
Additional stent dimensions ●
Characteristically similar material ●
Unknown predicate materials
Indwell time
Packaging ●
Sterilization ●
. Shelf-life

Technological Characteristics:

The following tests have been conducted to ensure reliable design and performance under the specified testing parameters on both subject devices. These tests include:

MRI Safety Testing
Dimensional
. Tensile Strength
I Shaft and Curl Elongation
Retention Strength ■
Flow Rate I
I Radiopacity
Kink
Compatibility with components ■
Artificial Urine Soak
. Accelerated Aging

The Black Silicone Filiform Double Pigtail Stent Set manufactured by Cook Incorporated (K172017) was used as a reference device to help support a substantial equivalence determination for the Dretler Ureteroscopy Stent Set.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in white, bold letters at the top. Below that, the word "MEDICAL" is written in white, smaller, bold letters.

COOK INCORPORATI 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM

Conclusion:

Packaging, sterilization, and shelf-life of the predicate device are not known, however, testing on the subject device has been performed on the subject device in accordance with all applicable standards and device requirements. The results of these tests show that the subject devices, Bander Ureteral Diversion Stent Set and Dretler Ureteroscopy Stent Set, met the design input requirements based on the intended use. Therefore, these data support the conclusion that this device does not raise new questions of safety or effectiveness and that the Bander Ureteral Diversion Stent Set is substantially equivalent to the predicate device the Percuflex™ Urinary Diversion Stent Set (K830803).

Furthermore, the results of these tests show that the subject Dreteroscopy Stent Set met the design input requirements based on the intended use. Therefore, these data support the conclusion that this device does not raise new questions of safety or effectiveness and that the subject Dretler Ureteroscopy Stent Set is substantially equivalent to the predicate device, the PercuflexTM Urinary Diversion Stent Set (K830803).

{6}------------------------------------------------

Indications for Use

510(k) Number (if known)

K181971

Device Name Bander Ureteral Diversion Stent Set

Indications for Use (Describe)

Used for intraoperative placement to stent the ureter and provide drainage from the external stoma during ureteroileal conduit construction and continent urinary diversions.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{7}------------------------------------------------

Indications for Use

510(k) Number (if known)

K181971

Device Name Dretler Ureteroscopy Stent Set

Indications for Use (Describe) This device is intended for post-ureteroscopy stenting of the ureter.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.

April 23, 2019

Cook Incorporated Paul Meyer Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404

Re: K181971

Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set Trade/Device Name: Regulation Number: 21 CFR$ 876.4620 Regulation Name: Ureteral Stent Regulatory Class: II Product Code: FAD Dated: April 4, 2019 Received: April 5, 2019

Dear Paul Meyer:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls' provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{9}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Regulation Number and Section

§ 876.4620 Ureteral stent.

(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).